Empatica has entered into a partnership with Mobilise-D to integrate the latter’s validated Digital Mobility Outcomes (DMOs) into its health monitoring platform with an aim to offer a unified solution for clinical professionals.

Mobilise-D is an initiative funded by the Innovative Medicines Initiative (IMI) and partners from the European Federation of Pharmaceutical Industries and Associations (EFPIA), with coordination led by England-based Newcastle University.

It focuses on advancing methods to assess people’s mobility in daily life using digital measures and wearable sensors. The Mobilise-D initiative aims to enhance therapeutic development, clinical practice, and precision medicine through innovative mobility analytics.

Empatica, on the other hand is engaged in artificial intelligence (AI)-driven digital biomarker development and patient monitoring solutions.

Its partnership with Mobilise-D is expected to help towards consolidating digital endpoints within clinical care and research.

Empatica aims to streamline the adoption of advanced mobility analytics, particularly through its EmbracePlus wearable device.

The collaboration is expected to simplify the integration of Mobilise-D’s algorithms into pharmaceutical studies, reducing the burden on patients and study sites.

Newcastle University professor and Mobilise-D co-lead Lynn Rochester said: “A major barrier to the implementation of digital outcomes in clinical trials is the availability of systems that can deliver accurate and reliable data in a timely and seamless manner.

“We are delighted that Empatica have chosen to integrate the Mobilise-D advanced mobility analytics, addressing this barrier and moving digital outcome assessment closer to a sustainable solution that drives much-needed innovation and harmonisation in clinical trials.”

Mobilise-D is said to be the first public programme to systematically combine device considerations, analytical and clinical validation, and patient and regulatory engagement to generate robust evidence for digital measures.

According to Empatica, the partnership is crucial for advancing the regulatory approval of digital endpoints in clinical drug development, particularly in interventional clinical trial settings.

Empatica’s US Food and Drug Administration (FDA)-cleared platform and technology are already utilised in research settings, spanning studies on various health conditions such as stress, sleep disorders, epilepsy, migraine, and mental health.

Mobilise-D, comprising experts from 22 academic institutions, 12 industry partners, and individuals with diverse health conditions, has focused on developing methods to accurately assess mobility changes in real-world environments. This initiative addresses conditions impacting mobility, including COPD, Parkinson’s disease, multiple sclerosis, hip fracture recovery, and congestive heart failure.

Empatica chief technology officer and co-founder Simone Tognetti said: “We are proud to be the first non-consortium member to implement the Mobilise-D consortium’s groundbreaking development and validation work.

“This means our Platform can now provide 25 new, validated outcomes for COPD, Parkinson’s, Multiple Sclerosis, and Proximal femoral fracture.

“The demand for high-quality, purpose-specific measures is immense, and Empatica is ready to support the dissemination of the consortium’s innovative work within the industry.”